FIELD: pharmacology.
SUBSTANCE: ready for infusion gemcitabine dosage form is described, comprising at least 100 ml of a stable solution of gemcitabine, or a pharmaceutically acceptable salt thereof in an aqueous solvent in the infusion container, wherein the solution is prepared for infusion and has a pH in the range of 6.0 to 8.0, and wherein gemcitabine infusion dosage form obtained by subjecting the solution of gemcitabine, or pharmaceutically acceptable salt thereof in a filled infusion container to terminal sterilisation by autoclaving. Also a kit ready for infusion is described, comprising a dosage form for infusion in the polymer infusion container, coated by an extra package.
EFFECT: obtaining of a stable gemcitabine solution at low temperatures for at least 6 months and at room temperature.
11 cl, 3 dwg, 6 tbl, 3 ex
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